Personal Satisfaction Clinical Trial
Official title:
Patient Satisfaction and Clinical Assessment of Biocompatible High Performance Polymers Crown Veneered With Visio.Lign Versus E-max Crown Veneered With E-max Veneering System in Anterior Aesthetic Zone.(Randomized Controlled Clinical Trial)
The aim of this study is to compare the patient satisfaction and clinical assessment (shade
matching, surface texture and marginal discoloration) of Bio- High Performance Polymers
(HPP) restoration versus E-max restoration compared to contralateral tooth in anterior zone.
Regardless E-max popularity in the dental field.
Roles and responsibilities
1. Nora Helmy Hasaneen (N.H.): Operator, data enterer and corresponding author; Assistant
lecturer fixed Prosthodontics Department, Faculty of Dentistry, Modern Technology
Institution (MTI) University, Egypt.
2. Dr. Ahmed Naguib Hussin( A.H.): Main supervisor, data monitoring and auditing;
Professor of fixed Prosthodontics, Faculty of Oral and Dental Medicine- Cairo
University, Egypt.
3. Dr.Gihan Al-Naggar (A. G.):Co-Supervisor, data monitoring and auditing; Professor of
fixed Prosthodontics, Faculty of Oral and Dental Medicine -Cairo University, Egypt.
3.Esraa Mohamed Odeuh(E.O.):Outcome assessors and data collection; Assistant lecturer, Fixed
Prosthodontics Department, Faculty of Oral and Dental Medicine, MTI University, Egypt.
4.Ahmed Gamal(A.G): Base line data collection, recruitment, sequence generation, allocation
concealment, patient retention and taking participants' consents; Resident Fixed
Prosthodontics Department, Faculty of Oral and Dental Medicine, MTI University, Egypt.
5.Eman Desouky (E.D.):Sample size calculation; Statistician, Faculty of Oral and Dental
Medicine, Cairo University, Egypt.
6. Evidence Based Dentistry Committee (CEBD) Help in reporting study protocol following
SPIRIT guidelines; Faculty of Oral and Dental Medicine, Cairo University, Egypt.
7.Research Ethics Committee (CREC): Protocol reviewer of the clinical trial in order to
protect the right, safety, dignity and well-being of the participants; Faculty of Oral and
Dental Medicine, Cairo University, Egypt.
8. Research Plan Committee (CRPC):For ensuring that this clinical trial following the
department research plan; Fixed prosthodontic Department, Faculty of Oral and Dental
Medicine, Cairo University, Egypt.
1. Intervention:
N.H. will perform conservative tooth preparation following the principles of all
ceramic crown preparation with shoulder subgingival finish line of thickness 1.2mm
using tapered stone with flat end attached to high speed headpiece with air and water
coolant, after local anesthesia has been given.
N.H. will take adequate 2ry Impression using non aqueous Elastomeric impression
materials Impregum™F (medium consistency, 3M ESPE ,) and bite registration will by pink
soft wax (Stardentalsupply) .
N.A. & E.O. will visually select the shade match using Vita Easyshade Compact (Vita
Zahnfabrik, Bad Sa¨ckingen,Germany). N.H will fabricate the temporary restoration using
Protemp™ 4 Temporisation Material(3M ESPE ) and cemented using non Eugenol Zinc Oxide
temporary cement TempBond™ Temporization (Kerrdentalsupply).
N.H will deliver Press Bio - HPP framework material veneered with visio lign veneering
material (Bredent) crown and cement it with 3M™ ESPE™ RelyX™ Unicem Self-Adhesive
Universal Resin Cement.
2. Comparator N.H. will perform conservative tooth preparation following the principles of
all ceramic crown preparation with shoulder subgingival finish line of thickness 1.2mm
using tapered stone with flat end attached to high speed headpiece with air and water
coolant, after local anesthesia has been given.
N.H. will take adequate 2ry Impression using non aqueous Elastomeric impression
materials Impregum™F (medium consistency, 3M ESPE ,) and bite registration will by pink
soft wax (Stardentalsupply) .
N.A. & E.O. will visually select the shade match using Vita Easyshade Compact (Vita
Zahnfabrik, Bad Sa¨ckingen,Germany). N.H will fabricate the temporary restoration using
Protemp™ 4 Temporisation Material(3M ESPE ) and cemented using non Eugenol Zinc Oxide
temporary cement TempBond™ Temporization (Kerrdentalsupply).
N.H will deliver E.max® framework veneered with E-max veneering System (Ivoclar
Vivadent) crown and cement it with 3M™ ESPE™ RelyX™ Unicem Self-Adhesive Universal
Resin Cement.
3. Outcomes
A. Primary outcome: Patient satisfaction:
E.O will measure patient satisfaction using Rating scores. The mean and standard deviation
for the Rating scores of the patients will be recorded at the time of crown cementation, 3,
6, 9 & 12 months after review for aesthetics.
B. Secondary outcome: Clinical assessment of the restoration:
E.O will evaluate shade matching, marginal discoloration and surface texture using modified
USPHS criteria scores. The mean and standard deviation for the USPHS criteria scores of the
patients will be recorded at the time of crown cementation 0, 3, 6, 9 & 12 months after
review for aesthetics.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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